Use of antibiotic prophylaxis in the prevention of postoperative infection of third impacted mandibular molars

Antibiotic Prophylaxis in the prevention of infectious complications in mandibular impacted third molars extraction: A randomized clinical trial

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12617001498381

Enrollment

120

Registered

2017-10-24

Start date

2016-05-02

Completion date

2017-11-21

Last updated

2022-02-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Third molar surgery is the most frequent procedure in oral and maxillofacial surgery. Surgical wound infection is the most prevalent complication. Determine if the use of 2 gr. of Amoxicillin as AP reduces the proportion of postoperative infectious complications in the impacted third molar extraction compared to placebo. To determine the proportion of postoperative infectious complications of the experimental group (2 gr Amoxicillin) and control group (placebo) derived from the exodoncia of impacted mandibular third molars. To compare the proportion of postoperative infectious complications of the experimental group versus the control group. To compare the proportion of rescue medication requirement associated with postoperative pain between the experimental group versus the control group. Describe any adverse reactions resulting from the use of 2 gr. Amoxicillin as AP.

Interventions

2 gr. Amoxicillin one hour before the surgery . Oral tablet

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

15 Years to 35 Years

Healthy volunteers

Inclusion criteria

Healthy patients between 15 to 35 years old: Clinically and radiographically presence at least of one impacted mandibular third molar,

Exclusion criteria

Pregnancy. Allergy to penicillin and its derivatives. Allergy to nonsteroidal anti-inflammatory drugs. Patients with gastric ulcer. Patients who have undergone any type of antibiotic treatment at least 30 days before surgery. Patients with pericoronaritis episode up to 7 days before the intervention. Patients with psychiatric illness. Immunocompromised Patients with addiction to narcotic drugs or illicit substances

Outcome results